A droplet delivery device and related methods for delivering precise and repeatable dosages to a subject for pulmonary use is disclosed. The droplet delivery device includes a housing, a reservoir, and ejector mechanism, and at least one differential pressure sensor. The droplet delivery device is automatically breath actuated by the user when the differential pressure sensor senses a predetermined pressure change within housing. The droplet delivery device is then actuated to generate a stream of droplets having an average ejected droplet diameter within the respirable size range, e.g, less than about 5 μm, so as to target the pulmonary system of the user.
Legal claims defining the scope of protection. Each claim is shown in both the original legal language and a plain English translation.
1. A drug delivery system for administering a therapeutic agent to a subject in need thereof as an ejected stream of droplets delivered via a piezoelectric actuated droplet delivery device to the pulmonary system of the subject to treat a disease disorder or condition, the system comprising: the piezoelectric actuated droplet delivery device; and a breathing assist device; wherein the piezoelectric actuated droplet delivery device comprises: a housing comprising a mouthpiece located at an airflow exit of the housing, and an airflow inlet flow element positioned at an airflow entrance of the housing; a reservoir disposed within or in fluid communication with the housing for receiving a volume of fluid including the therapeutic agent; an ejector mechanism in fluid communication with the reservoir, the ejector mechanism comprising a piezoelectric actuator and an aperture plate, the aperture plate having a plurality of openings formed through its thickness and the piezoelectric actuator operable to oscillate the aperture plate at a frequency to thereby generate the ejected stream of droplets; at least one differential pressure sensor positioned within the housing; the at least one differential pressure sensor configured to activate the ejector mechanism upon sensing a pre-determined pressure change within the housing to thereby generate the ejected stream of droplets; the ejector mechanism configured to generate the ejected stream of droplets wherein at least about 70% of the droplets have an average ejected droplet diameter of less than about 5 microns, such that at least about 70% of the mass of the ejected stream of droplets is delivered to the pulmonary system of the subject during use so as to treat the disease, disorder, or condition; the housing, airflow inlet flow element, and mouthpiece configured to facilitate non-turbulent airflow across an exit side of the aperture plate and to provide sufficient non-turbulent airflow through the device during use.
This invention relates to drug delivery systems and specifically addresses the challenge of efficiently delivering therapeutic agents to the pulmonary system. The system comprises a piezoelectric actuated droplet delivery device and a breathing assist device. The droplet delivery device includes a housing with a mouthpiece at the exit and an airflow inlet. A reservoir within or connected to the housing holds a fluid containing the therapeutic agent. An ejector mechanism, in fluid communication with the reservoir, features a piezoelectric actuator and an aperture plate with multiple openings. The piezoelectric actuator oscillates the aperture plate to create a stream of droplets. The system incorporates at least one differential pressure sensor within the housing. This sensor is designed to activate the ejector mechanism when a specific pressure change is detected, thereby generating the droplet stream. The ejector mechanism is configured to produce droplets where at least 70% have a diameter less than 5 microns. This ensures that at least 70% of the droplet mass is delivered to the pulmonary system for treating diseases, disorders, or conditions. The housing, airflow inlet, and mouthpiece are designed to promote non-turbulent airflow across the aperture plate and through the device during operation.
2. The drug delivery system of claim 1 , wherein the breathing assist device is a mechanical ventilator or a continuous positive airway pressure (CPAP) machine.
A drug delivery system integrates with a breathing assist device, such as a mechanical ventilator or a continuous positive airway pressure (CPAP) machine, to administer medications directly into a patient's respiratory tract. The system includes a drug reservoir, a dosing mechanism, and a delivery conduit that interfaces with the breathing assist device. The dosing mechanism controls the release of a predetermined amount of medication from the reservoir, which is then delivered through the conduit into the patient's airway during inhalation. This ensures precise dosing and synchronization with the patient's breathing cycle. The system may also include sensors to monitor airflow, pressure, or medication concentration, providing feedback to adjust dosing in real-time. The integration with ventilators or CPAP machines allows for seamless administration of respiratory medications, such as bronchodilators or anti-inflammatory drugs, without disrupting the patient's breathing support. This approach improves treatment efficiency, reduces side effects, and enhances patient compliance by automating drug delivery during mechanical ventilation or CPAP therapy. The system is particularly useful in clinical settings where patients require both respiratory support and medication administration.
3. The drug delivery system of claim 1 , wherein the piezoelectric actuated droplet delivery device is positioned in-line with an airflow tube of the breathing assist device to provide delivery of the ejected stream of droplets into an airflow of the breathing assist device.
This invention relates to a drug delivery system integrated with a breathing assist device, such as a ventilator or nebulizer, to enhance medication delivery efficiency. The system addresses the challenge of effectively administering aerosolized drugs to patients receiving respiratory support, where conventional methods may result in drug loss or inconsistent dosing due to improper positioning or airflow disruptions. The drug delivery system includes a piezoelectric actuated droplet delivery device that generates a controlled stream of drug-containing droplets. This device is positioned in-line with the airflow tube of the breathing assist device, ensuring direct delivery of the droplets into the airflow path. By integrating the droplet delivery mechanism directly into the airflow tube, the system minimizes drug wastage and improves deposition efficiency in the patient's respiratory tract. The piezoelectric actuator provides precise control over droplet size and ejection timing, allowing for optimized drug delivery synchronized with the patient's breathing cycle. The system may also include a controller to regulate the operation of the piezoelectric device, ensuring consistent droplet generation and delivery. Additionally, the airflow tube may be designed to facilitate uniform mixing of the drug droplets with the airflow, further enhancing drug distribution. This in-line configuration ensures that the medication is delivered directly into the patient's respiratory system without external interference, improving therapeutic outcomes for patients requiring respiratory support.
4. The drug delivery system of claim 1 , wherein the aperture plate of the piezoelectric actuated droplet delivery device comprises a domed shape.
The invention relates to a drug delivery system that uses a piezoelectric actuated droplet delivery device to dispense precise doses of medication. The system addresses the challenge of accurately delivering small, controlled quantities of liquid drugs, which is critical in medical applications where dosage precision is essential. The key innovation involves an aperture plate with a domed shape, which improves the performance of the droplet delivery mechanism. The domed shape enhances the efficiency of droplet formation and ejection, ensuring consistent and reliable drug delivery. This design modification helps prevent issues like droplet splitting or irregular droplet sizes, which can occur with flat or improperly shaped aperture plates. The piezoelectric actuator generates mechanical vibrations that force the liquid through the domed aperture, producing uniform droplets. The system is particularly useful in applications requiring high precision, such as pharmaceutical manufacturing, medical diagnostics, or personalized drug dosing. The domed aperture plate ensures that the droplets are ejected with minimal energy loss and maximum accuracy, making the system more efficient and reliable for drug delivery applications.
5. The drug delivery system of claim 1 , wherein the ejector mechanism is orientated with reference to the housing such that the ejected stream of droplets is directed into and through the housing at an approximate 90 degree change of trajectory prior to expulsion from the housing.
This invention relates to a drug delivery system designed to improve the accuracy and efficiency of drug administration. The system addresses the challenge of precisely directing a stream of drug droplets to a target site, such as the respiratory tract, while minimizing loss or deviation during delivery. The core innovation involves an ejector mechanism that is strategically oriented within the housing to redirect the ejected stream of droplets. The mechanism ensures that the droplets undergo an approximate 90-degree change in trajectory as they pass through the housing before being expelled. This redirection helps align the droplets with the intended delivery path, enhancing targeting accuracy and reducing waste. The housing structure supports this redirection, ensuring that the droplets are properly channeled toward the target area. The system may also include additional components, such as a reservoir for storing the drug and a control mechanism for regulating the ejection process. The overall design aims to optimize drug delivery by improving droplet trajectory control, making it particularly useful in medical applications where precise dosing is critical.
6. The droplet delivery system of claim 1 , wherein the reservoir is removably coupled with the housing.
A droplet delivery system is designed to precisely dispense small volumes of liquid, such as in medical, laboratory, or industrial applications. The system includes a housing that contains a reservoir for storing the liquid to be dispensed. The reservoir is removably coupled to the housing, allowing for easy replacement or refilling without disassembling the entire system. This modular design enhances usability and reduces downtime. The system may also include a dispensing mechanism, such as a nozzle or pump, to control the release of droplets. The removable reservoir ensures compatibility with different liquids or volumes, improving versatility. The housing may further include structural features to secure the reservoir in place during operation, preventing leaks or misalignment. This design is particularly useful in applications requiring frequent liquid changes or maintenance, such as in automated liquid handling systems or medical devices. The removable coupling may involve mechanical fasteners, snap-fit connections, or threaded attachments, depending on the specific application. The system ensures precise and consistent droplet delivery while maintaining ease of use and adaptability.
7. The drug delivery system of claim 1 , wherein the reservoir is coupled to the ejector mechanism to form a combination reservoir/ejector mechanism module, and the combination reservoir/ejector mechanism module is removably coupled with the housing.
This invention relates to a drug delivery system designed to improve the modularity and ease of use in administering medications. The system addresses the challenge of integrating a drug reservoir with an ejection mechanism in a compact, user-friendly design. The reservoir, which stores the drug, is directly coupled to the ejection mechanism, forming a single, unified module. This combination reservoir/ejector mechanism module simplifies assembly and maintenance by allowing the entire unit to be easily attached or detached from the housing of the drug delivery system. The housing provides structural support and may include additional components such as controls, power sources, or user interfaces. By modularizing the reservoir and ejection mechanism, the system enables quick replacement or servicing of these components without disassembling the entire device. This design enhances usability, reduces downtime, and ensures reliable drug delivery. The system is particularly useful in medical devices requiring precise and repeatable dosing, such as insulin pumps or automated injectors.
8. The drug delivery system of claim 1 , further comprising a wireless communication module.
A drug delivery system is designed to administer medication to a patient in a controlled and automated manner, addressing challenges in precise dosing, patient compliance, and real-time monitoring. The system includes a reservoir for storing the drug, a dispensing mechanism to release the drug at predetermined intervals or based on sensor feedback, and a control unit that regulates the dispensing process. The control unit may incorporate feedback from biosensors or user inputs to adjust dosage in real time, ensuring accurate and personalized treatment. To enhance functionality, the system includes a wireless communication module that enables remote monitoring and control. This module allows healthcare providers to track medication adherence, adjust dosing parameters, and receive alerts if deviations occur. The wireless communication module can also transmit data to a central database or a patient's mobile device, facilitating remote patient management and improving treatment outcomes. Additionally, the module may support bidirectional communication, enabling the system to receive updates or new dosing protocols wirelessly, ensuring flexibility and adaptability in treatment plans. The integration of wireless communication enhances the system's ability to provide timely and accurate drug delivery while reducing the need for manual intervention.
9. The drug delivery system of claim 1 , wherein the piezoelectric actuated droplet delivery device further comprises one or more sensors selected from an infra-red transmitter, a photodetector, an additional pressure sensor, and combinations thereof.
This invention relates to a drug delivery system that uses a piezoelectric actuated droplet delivery device to administer precise doses of medication. The system addresses challenges in accurate drug dosing, particularly for treatments requiring controlled, small-volume deliveries. The piezoelectric actuator generates controlled vibrations to produce droplets of consistent size, ensuring precise medication administration. The system includes one or more sensors to enhance functionality. These sensors may include an infrared transmitter for detecting droplet formation or patient interaction, a photodetector for monitoring droplet trajectory or delivery confirmation, an additional pressure sensor for measuring fluid pressure within the system, or combinations of these sensors. The sensors provide real-time feedback to optimize dosing accuracy and ensure proper operation. The system is designed for applications where precise, automated drug delivery is critical, such as in medical treatments requiring controlled administration of liquids or suspensions. The inclusion of multiple sensor types allows for adaptive adjustments based on environmental or operational conditions, improving reliability and performance.
10. The drug delivery system of claim 1 , wherein the breathing assist device is a mechanical ventilator, the therapeutic agent is an antibiotic, and the disease, disorder or condition is ventilator-assisted pneumonia (VAP).
This invention relates to a drug delivery system designed to treat ventilator-assisted pneumonia (VAP) by integrating a mechanical ventilator with an antibiotic delivery mechanism. The system is specifically configured to administer therapeutic agents directly through the ventilator, ensuring precise and controlled dosing to patients requiring mechanical ventilation. The mechanical ventilator provides respiratory support while simultaneously delivering the antibiotic, optimizing treatment efficiency and reducing the risk of infection. The system is tailored to address the challenges of VAP, a common and serious complication in critically ill patients on ventilators, by ensuring consistent and targeted antibiotic administration. The integration of the ventilator with the drug delivery mechanism allows for synchronized treatment, minimizing the need for separate interventions and improving patient outcomes. The system may include features such as automated dosing, real-time monitoring, and feedback mechanisms to adjust treatment based on patient response, ensuring optimal therapeutic effectiveness. This approach enhances the management of VAP by leveraging existing ventilator infrastructure while improving drug delivery accuracy and patient safety.
11. The drug delivery system of claim 10 , wherein the piezoelectric actuated droplet delivery device is activated during an inspiration cycle of the mechanical ventilator.
This invention relates to a drug delivery system integrated with a mechanical ventilator for precise aerosolized medication administration. The system addresses the challenge of delivering drugs efficiently to a patient's respiratory tract during mechanical ventilation, ensuring optimal therapeutic effect while minimizing waste and side effects. The core component is a piezoelectric actuated droplet delivery device that generates controlled droplets of medication. This device is synchronized with the ventilator's operation, specifically activating during the inspiration cycle when the patient inhales, ensuring that the drug is delivered directly into the lungs. The piezoelectric actuator provides rapid and precise droplet formation, allowing for accurate dosing and consistent particle size. The system may also include sensors to monitor ventilator parameters and adjust drug delivery accordingly, enhancing treatment efficacy. By coordinating drug delivery with the ventilator's breathing cycle, the system improves drug deposition in the lungs, reduces drug loss, and minimizes potential side effects from improper dosing. The invention is particularly useful in critical care settings where precise medication administration is essential for patient recovery.
12. The drug delivery system of claim 1 , wherein the breathing assist device is a CPAP machine.
A drug delivery system integrates with a breathing assist device, specifically a continuous positive airway pressure (CPAP) machine, to administer therapeutic agents to a patient during respiratory therapy. The system addresses the challenge of delivering drugs efficiently while maintaining the patient's comfort and compliance with respiratory treatment. The CPAP machine provides a controlled airflow to the patient's airways, and the drug delivery system is designed to introduce pharmaceutical compounds into this airflow. The system may include a reservoir or cartridge containing the drug, a mechanism to release the drug into the airflow, and a controller to regulate dosage and timing. The integration ensures that the drug is delivered in a precise and controlled manner, synchronized with the patient's breathing cycle. This approach enhances drug absorption and therapeutic effectiveness while minimizing side effects. The system is particularly useful for conditions requiring long-term respiratory support, such as chronic obstructive pulmonary disease (COPD) or sleep apnea, where concurrent drug delivery can improve treatment outcomes. The design ensures compatibility with existing CPAP devices, allowing seamless adoption in clinical and home settings.
13. The drug delivery system of claim 12 , further comprising a cardiac monitoring module configured to monitor and detect cardiac events, wherein the cardiac monitoring module is in communication with a controller.
This invention relates to a drug delivery system with integrated cardiac monitoring for managing medical conditions. The system addresses the need for real-time patient monitoring and automated drug administration to improve treatment outcomes, particularly for conditions requiring precise timing and dosage adjustments, such as arrhythmias or heart failure. The drug delivery system includes a cardiac monitoring module that continuously tracks cardiac activity to detect events like arrhythmias, bradycardia, or tachycardia. The module communicates with a controller, which processes the monitored data to determine if drug delivery is necessary. The controller can adjust dosage or timing based on the detected cardiac events, ensuring timely and appropriate treatment. The system may also include a drug reservoir, a delivery mechanism (such as a pump or catheter), and a user interface for manual overrides or settings adjustments. The cardiac monitoring module may use sensors like electrocardiogram (ECG) leads or implantable devices to capture heart signals. The controller analyzes these signals to identify abnormal rhythms or other cardiac conditions, triggering automated drug delivery if predefined thresholds are met. The system may also log data for later review by healthcare providers, enabling personalized treatment adjustments. This invention improves upon prior systems by integrating cardiac monitoring directly into the drug delivery process, reducing delays in treatment and enhancing patient safety through automated, data-driven interventions.
14. The drug delivery system of claim 13 , wherein the therapeutic agent is a cardiac medication, and the disease, disorder or condition is a cardiac condition.
This invention relates to a drug delivery system designed to administer therapeutic agents for treating cardiac conditions. The system includes a reservoir containing a cardiac medication, a delivery mechanism to release the medication in a controlled manner, and a monitoring component to track physiological parameters such as heart rate, blood pressure, or other cardiac-related metrics. The system may also incorporate feedback mechanisms to adjust dosage based on real-time patient data, ensuring precise and timely administration of the medication. The delivery mechanism can be implanted or wearable, allowing for continuous or on-demand treatment. The invention addresses the need for accurate, personalized cardiac medication delivery to improve patient outcomes in conditions like arrhythmias, heart failure, or myocardial infarction. By integrating monitoring and adaptive dosing, the system aims to reduce side effects and enhance therapeutic efficacy compared to traditional methods. The invention may also include safety features to prevent overdosing or malfunction, ensuring patient safety during treatment.
15. The drug delivery system of claim 14 , wherein the piezoelectric actuated droplet delivery device is activated during an inspiration cycle of the subject when the cardiac monitoring module detects a cardiac event.
This invention relates to a drug delivery system designed for precise and synchronized administration of medications, particularly for respiratory or cardiovascular applications. The system addresses the challenge of delivering drugs at optimal times to enhance efficacy and reduce side effects, leveraging real-time physiological monitoring to coordinate dosing with natural bodily cycles. The system includes a piezoelectric actuated droplet delivery device capable of dispensing precise drug doses in droplet form. This device is integrated with a cardiac monitoring module that continuously tracks the subject's cardiac activity, detecting specific cardiac events such as heartbeats or arrhythmias. The system is configured to activate the droplet delivery device during the subject's inspiration cycle, ensuring that the drug is administered when the subject inhales, which can improve drug absorption in respiratory applications. The synchronization with cardiac events allows for tailored dosing that aligns with the body's physiological rhythms, potentially improving therapeutic outcomes. The piezoelectric actuator provides rapid and controlled droplet formation, enabling accurate dosing. The cardiac monitoring module may use sensors like electrocardiograms (ECGs) to detect cardiac events, triggering the delivery device accordingly. This approach can be particularly useful for treatments requiring precise timing, such as respiratory medications or cardiovascular therapies where drug delivery timing impacts effectiveness. The system may also include feedback mechanisms to adjust dosing based on real-time physiological data, enhancing personalization and safety.
16. A method for treating a disease, condition or disorder using a drug delivery system of claim 1 , the method comprising: (a) positioning the piezoelectric actuated droplet delivery device in-line with an airflow tube of the breathing assist device; (b) generating the ejected stream of droplets via the piezoelectric actuated droplet delivery device, wherein at least about 70% of the ejected stream of droplets have an average ejected droplet diameter of less than about 5 μm; and (c) providing the ejected stream of droplets into an airflow of the breathing assist device so as to deliver the ejected stream of droplets to the pulmonary system of the subject such that at least about 70% of the mass of the ejected stream of droplets is delivered to the pulmonary system of the subject during use.
This invention relates to a method for treating respiratory diseases or conditions using a drug delivery system integrated with a breathing assist device. The system employs a piezoelectric actuated droplet delivery device to generate a fine aerosol of medication droplets. The device is positioned in-line with the airflow tube of the breathing assist device, ensuring direct delivery of the aerosol into the subject's respiratory system. The method involves generating an ejected stream of droplets where at least 70% of the droplets have an average diameter of less than 5 micrometers, optimizing pulmonary deposition. The droplets are then introduced into the airflow of the breathing assist device, ensuring that at least 70% of the mass of the ejected stream reaches the pulmonary system. This approach enhances drug delivery efficiency by minimizing droplet loss and improving deposition in the lungs, addressing challenges in treating respiratory conditions where precise and consistent dosing is critical. The piezoelectric actuation ensures controlled droplet generation, while the small droplet size and high mass delivery efficiency improve therapeutic outcomes.
17. The method of claim 16 , wherein the breathing assist device is a mechanical ventilator or a continuous positive airway pressure (CPAP) machine.
A breathing assist device, such as a mechanical ventilator or a continuous positive airway pressure (CPAP) machine, is used to support or replace a patient's respiratory function. These devices are critical in medical settings where patients cannot breathe adequately on their own, such as in cases of respiratory failure, sleep apnea, or during anesthesia. The device delivers pressurized air or oxygen to the patient's airways, ensuring proper oxygenation and ventilation. Mechanical ventilators are typically used in intensive care units for patients requiring full respiratory support, while CPAP machines are commonly used for treating sleep apnea by maintaining airway patency during sleep. The device may include features such as adjustable pressure settings, flow control mechanisms, and monitoring systems to ensure optimal therapy delivery. The invention may also incorporate sensors to detect patient breathing patterns and adjust airflow accordingly, improving comfort and efficacy. Additionally, the device may be designed for portability, allowing use in home care settings or during patient transport. The system may further include alarms or alerts to notify healthcare providers of potential issues, such as disconnections or pressure fluctuations. The overall goal is to provide reliable, safe, and effective respiratory support tailored to the patient's needs.
18. The method of claim 16 , wherein the disease condition or disorder is selected from VAP and cardiac events.
This invention relates to a method for detecting or monitoring disease conditions or disorders, specifically ventilator-associated pneumonia (VAP) and cardiac events, using a wearable or implantable medical device. The device includes sensors that continuously measure physiological parameters such as respiratory rate, heart rate, blood pressure, and oxygen saturation. The method involves analyzing these parameters in real-time to identify patterns or deviations indicative of VAP or cardiac events. The device may also incorporate machine learning algorithms trained on historical patient data to improve detection accuracy. If a potential condition is detected, the device alerts healthcare providers or initiates automated interventions, such as adjusting ventilation settings or administering medication. The system may also log data for long-term monitoring and trend analysis. The invention aims to provide early and accurate detection of VAP and cardiac events, reducing complications and improving patient outcomes. The method ensures continuous monitoring, minimizing the need for invasive procedures and enhancing patient safety.
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May 3, 2017
March 29, 2022
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